Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021744
Company: DEPOMED INC
Company: DEPOMED INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROQUIN XR | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/25/2011 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021744s016lbl.pdf | |
| 12/29/2010 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021744s014lbl.pdf | |
| 04/27/2009 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021744s012lbl.pdf | |
| 10/03/2008 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021744s008lbl.pdf | |
| 09/04/2007 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021744s005lbl.pdf | |
| 08/10/2007 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021744s004lbl.pdf | |
| 08/01/2007 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021744s003lbl.pdf | |
| 08/17/2006 | SUPPL-2 | Manufacturing (CMC)-Expiration Date | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021744s002lbl.pdf | |
| 05/19/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021744lbl.pdf |